UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer
Acronym	FOLFIRINOX for advanced biliary tract cancer
Scientific Title	A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer
Scientific Title:Acronym	FOLFIRINOX for advanced biliary tract cancer
Region	Japan

Condition
Condition	Biliary tract cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the safety and the efficacy of FOLFIRINOX in patients with advanced biliary tract cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Response rate, disease control rate, overall survival, and safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	FOFIRINOX which is a combination chemotherapy of oxaliplatin, irinotecan, leucovorin, and fluorouracil will be given every 2 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) unresectable or recurrent biliary tract cancer 2) histologically or cytologically confirmed adenocarcinoma 3) no prior chemotherapy or radiation therapy 4) age of 20-75 years 5) an Eastern Cooperative Oncology Group PS of 0 or 1 6) at least one measurable lesion 7) adequate hematological, liver, and renal function (white blood cell count=> 10 000/mm3, neutrophil count=>2000/mm3, hemoglobin=>9.0 g/dL, platelet count=>100 000/mm3, aspartate transaminase and alanine transaminase <=2.5x upper limit of normal, total bilirubin <=1.2x upper limit of normal, Creatinine clearance =>50 ml/min). 8) written informed consent
Key exclusion criteria	1) synchronous or metachronous double cancer, excluding carcinoma in situ or intramucosal carcinoma cured by local treatment 2) allergy for contrast medium for CT and MRI 3) brain metastasis 4) blood transfusion, blood products, or hematopoietic growth factor preparations such as G-CSF within 7 days before enrollment 5) UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UGT1A1*6 and UGT1A1*28 6) apparent coelomic fluid (pleural effusion, ascites, or pericardial fluid) 7) serious concomitant diseases 8) abnormal findings in ECG 9) intestinal pneumonia 10) poorly controlled diabetes 11) diarrhea including watery stools within 3 days before enrollment 12) grade 2 or higher peripheral sensory neuropathy 13) active infection other than HBV or HCV 14) serious allergy 15) history of severe drug allergy 16) pregnant or lactating woman 17) disqualified for trial by principal investigator.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Yousuke Middle name Last name Nakai
Organization	The University of Tokyo
Division name	Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine,
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	naminatsu.takahara@gmail.com

Public contact
Name of contact person	1st name Naminatsu Middle name Last name Takahara
Organization	The University of Tokyo
Division name	Department of Gastroenterology, Graduate School of Medicine,
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	naminatsu.takahara@gmail.com

Sponsor
Institute	Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (grant number 2018-2020)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo, Clinical Research Review Board
Address	7-3-1, Hongo,Bunkyo-ku,Tokyo, Tokyo
Tel	03-5841-0818
Email	mgr-ohrs@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs 031180082
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院（東京都）、京都大学病院(京都府)、大阪国際がんセンター(大阪府)、がん研有明病院(東京都)、杏林大学（東京都）、順天堂大学順天堂医院(東京都)、国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、神奈川県立がんセンター(神奈川県)、徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 01 Month 21 Day
Date of IRB	2016 Year 01 Month 21 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 29 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023993